MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO2; CAROTID SINUS LEAD

Model Number	1036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Voice alteration (4906)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.Since implant, the patient experienced worsening vocal issues in the form of partial vocal paralysis and increased dyspnea on exertion (doe) and shortness of breath (sob).In the opinion of the physician, the root cause of the partial vocal paralysis was unknown but possibly related to nerve damage or vocal cord trauma during barostim implant as the onset was post-barostim implant.In the opinion of the physician, the doe and sob were not due to barostim as the patient had recently experienced covid.A barostim follow-up was scheduled for (b)(6) 2025.The patient was referred to physical therapy for their voice and vocal cords with the evaluation scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was possibly related to nerve damage or vocal cord trauma during barostim implant.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.Since implant, the patient experienced worsening vocal issues in the form of partial vocal paralysis and increased dyspnea on exertion (doe) and shortness of breath (sob).In the opinion of the physician, the root cause of the partial vocal paralysis was unknown but possibly related to nerve damage or vocal cord trauma during barostim implant as the onset was post-barostim implant.In the opinion of the physician, the doe and sob were not due to barostim as the patient had recently experienced covid.A barostim follow-up was scheduled for (b)(6) 2025.The patient was referred to physical therapy for their voice and vocal cords, and physical therapy was scheduled to begin in mid-(b)(6).As of (b)(6) 2025, no change to the vocal issues had occurred.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h11.Cvrx id# (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, b5, g2, g6, h2, h11 cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.Since implant, the patient experienced worsening vocal issues in the form of partial vocal paralysis and increased dyspnea on exertion (doe) and shortness of breath (sob).In the opinion of the physician, the root cause of the partial vocal paralysis was unknown but possibly related to nerve damage or vocal cord trauma during barostim implant as the onset was post-barostim implant.In the opinion of the physician, the doe and sob were not due to barostim as the patient had recently experienced covid.A barostim follow-up was scheduled for (b)(6) 2025.The patient was referred to physical therapy for their voice and vocal cords, and physical therapy was scheduled to begin in mid-(b)(6) 2025, no change to the vocal issues had occurred.As of (b)(6) 2026, the patient had started vocal physical therapy, and there was some improvement.It was planned to continue physical therapy.
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.Since implant, the patient experienced worsening vocal issues in the form of partial vocal paralysis and increased dyspnea on exertion (doe) and shortness of breath (sob).In the opinion of the physician, the root cause of the partial vocal paralysis was unknown but possibly related to nerve damage or vocal cord trauma during barostim implant as the onset was post-barostim implant.In the opinion of the physician, the doe and sob were not due to barostim as the patient had recently experienced covid.A barostim follow-up was scheduled for (b)(6) 2025.The patient was referred to physical therapy for their voice and vocal cords, and physical therapy was scheduled to begin in mid-(b)(6).As of (b)(6)2025, no change to the vocal issues had occurred.As of (b)(6)2026, the patient had started vocal physical therapy, and there was some improvement.It was planned to continue physical therapy.As of (b)(6)2026, no additional intervention beyond physical therapy was planned.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h11.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO2
• Common Device Name: CAROTID SINUS LEAD
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 23790210
• Report Number: 3007972010-2025-00128
• Device Sequence Number: 5712757
• Product Code: DSR
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 03/10/2026; 06/04/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/23/2026; 04/06/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White